Method and insert for modifying eye color

ABSTRACT

A method and intrastroma insert are adapted to modify eye color. The insertion of opaque material into the stromal space is a means of changing the color and/or design of the stroma and, apparently, the iris. Biocompatible inserts include a slurry of biocompatible material, a fabric including opacified material, and a thin, permeable film material incorporating some opaque materials that may also alter the shape of the cornea to improve aberrational shape.

This application is a continuation application of U.S. patentapplication Ser. No. 10/918,495 filed Aug. 13, 2004.

The present invention relates to a method for insertion ofphotoabsorptive and/or photoreactive material within the cornea of aneye, specifically within the stroma, for modifying eye color and otheraspects of appearance, normalizing iris deficiencies and structure,absorbing radiation, and correcting aberrational corneal anatomy. Theinsert is formed of biocompatible, noneroding and positionally stablematerials, such as hydrogels and hydrogel polymacralades, implantable inthe stroma.

BACKGROUND

The iris is an anatomic structure that defines and surrounds thepupillary aperture that allows light into the eye's interior. Pigment inthe iris, specifically the amount and color of the pigment, determineshuman eye color. The primary function of the iris, along with the eyelids, is to control the amount of light that reaches the retina.Excessive exposure to sunlight may contribute to cataracts andage-related macular degeneration. People with insufficient pigment inthe iris are prone to these diseases and to poor vision from glare andlens effects from the rim of the human lens. The greater the amount ofpigment in the eye, the darker the color of the iris. Darker iris colorprovides greater from ultraviolet light and makes eyes less-sensitive tobright light. Most of the world's population has darker eye color.

In addition to the biological function, the iris is the eye's mostsignificant cosmetic feature. Color and patterns in the irischaracterize the belief that the eyes are the “window to the soul.”

Historically, radially tinted contact lens have been the primary methodused to adjust the apparent color of the iris, but contact lenses havesubstantial and well-recognized limitations in this regard. For example,contact lenses are typically readily distinguishable from natural eyecolor. The lenses “float”, thereby moving the tinted portion over thepupil and causing the eyes to appear to be looking in differentdirections. Contact lenses also present risks of infection to thecornea, which in turn can lead to scarring and poor vision. Contactlenses are inconvenient, because they generally should be removed on adaily basis to minimize the risk of infection. Even so, contact lensesare not a viable option for a significant portion of the populationincluding those with dry eyes or other intolerance factors.

Substantial research and clinical study exist with respect to eyeimplants for purposes of improving the refractive performance of an eyeand thereby improve vision. These corrective implants are transparentand often involve positioning within or near the pupillary axis—theeye's direct line of sight. The implants are shaped and dimensioned tomodify the angulation of light rays passing through the cornea to changethe eye's refractive properties.

A permanent or semi-permanent alternative means of coloring the eyewould have several immediate benefits. Eliminating the need for contactlenses would eliminate contact lens related infections and problems thatresult from mishandling such as leaving a lens in the eye too long.Darkening the cornea of those with little or no iris color due, forexample, to genetic circumstances would reduce excessive sunlightexposure to the retina, improve vision and provide a desirable cosmeticenhancement. Using corneal opacification to make light exposurerelatively uniform in those with surgical or traumatic irregularities ofthe iris would provide similar benefits. Mitigating iris color flawswould improve self-image and potentially improve vision. Providing awidely available means of cosmetically enhancing eye color would providea means for self-expression and potentially improve vision.

“Aberration” is distortion in the shape of the cornea leading tomisdirection of the light ray off the desired path to the center ofvision the macula. A common form in of aberration is called sphericalaberration and is the tendency of the cornea to curve away from themidline or visual axis too quickly. This leads to progressive steepeningat the rim and near sightedness that is greater at the rim than thecenter.

Wavefront analysis is performed by an instrument called an aberometer.The aberometer can detect optical errors at a fine level. Wavefronttechnology assesses every ray of light that enters the eye and thendetermines what changes will produce the clearest image. Therefore,wavefront analyzers precisely measure the overall refractive error ofthe entire eye, including any aberrations caused by the tear film,anterior and posterior cornea, lens, vitreous and retina. Remember thatcorneal topography systems can define corneal irregularities, but theycannot detect aberrations in other parts of the eye.

SUMMARY

Accordingly, it is an object of the present invention to overcome theforegoing drawbacks and limitations of existing eye color modificationmethods, permit the modification of other aspects of the eye'sappearance, provide an improved means of normalizing iris deficienciesand structure, and provide a means of absorbing radiation and correctingaberrational corneal anatomy through the use of biocompatible,noneroding and positionally stable materials, such as hydrogels andhydrogel polymacralades, implanted in the stroma.

In one example, a method of modifying eye color includes forming achannel within a plane around the pupil of an eye, wherein the channelis located in the stroma portion of the eye. The cornea of the eye isslitted to gain access to the channel. A biocompatible material is theninserted into the channel, wherein the biocompatible material is atleast partially opacified. The channel may be formed by using a lasertechnique. The channel may be fanned by using a surgical blade. Thechannel may comprise a substantially flat, annular shape having an outerdiameter proximate the limbus of the eye. The inside diameter of theannular shape may be proximate the daylight margin of the pupil. Thechannel may extend around the entire circumference of the pupil. Thebiocompatible material may be comprised of a slurry of particles with atleast some of the particles comprising an opacified material. The shapeof the particles may include a shaped selected from the group consistingof flat round, spherical, ovalized, diamond-shaped, star-shaped,triangular and combinations thereof. The biocompatible material may becomprised of a polymer fabric comprising an opacified material. Thebiocompatible material may also be comprised of a thin polymer filmcomprising an opacified material. The film may have a thickness of about3 microns or less.

In another example, an intrastromal eye insert comprises a biocompatiblematerial that is at least partially opacified. The biocompatiblematerial may comprise a slurry of particles with at least some ofparticles comprising an opacified material. The biocompatible materialmay be comprised of a polymer fabric comprising an opacified material.The biocompatible material, may be comprised of a thin polymer filmcomprising an opacified material.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation, cross sectional view of an eye.

FIG. 2 is a front elevation view of an eye.

FIG. 3 is a side elevation, cross sectional view of the front portion ofan eye.

FIGS. 3A-D are similar to FIG. 3 but demonstrate variations in width ofthe channel described herein.

FIG. 4 is a front elevation view of an eye having a slurry of opacifiedmaterial placed in a channel around the pupil.

FIG. 4A is a side elevation, cross sectional view of a particle in theslurry shown in FIG. 4.

FIG. 5 is a front elevation view of an eye having a fabric insert in achannel around the pupil.

FIG. 6 is a front elevation view of a thin film insert in a channelaround the pupil.

FIG. 7A is a view of the front of an eye having an insert around thepupil.

FIG. 7B is a view of the front of an eye having different possibledesigns implantable in the stroma.

FIG. 8 is a side elevation cross sectional view of the cornea of an eye.

FIG. 9 is a side elevation view of the cornea shown in FIG. 8 whereinthe Bowman's membrane has been stained with a pigment.

FIG. 10 is a view of the front of an eye having a plurality of channelswith inserts therein.

FIG. 11 is a side elevation, cross-sectional view of an eye havingopacified material injected into it.

DETAILED DESCRIPTION

The invention is directed to an intrastromal insert adapted to modifyeye color. The invention is further directed to a method of placing aninsert into the stromal space to modify eye color. The insertion ofopaque material into the stromal space is a means of changing the colorand/or design of the stroma and, apparently, the iris. While theinvention is described herein in the context of several examples, thoseof skill in the art will understand that additional materials may beused as an insert and different methods may be used to place that insertwithin the stromal space. These variations known to those of skill inthe art are encompassed by and included in the present invention.

FIGS. 1 and 2 illustrate a human eye before its color has been modifiedin accordance with methods and inserts described herein. FIGS. 1 and 2are used to define the parts of the eye as those terms are used herein.The eye 10 includes the round pupil 11 in the center of the eye. Thepupil 11 is defined by the iris 12. The iris 12 may dilate or contractdepending on the given lighting conditions that are present at a giventime, so the pupil may be larger or smaller depending on conditions. Thecornea 20 is the clear, layered portion of the eye 10 that allows lightto pass into the eye. The cornea 20 has several layers. The epithelium21 is the outer most layer of the cornea 20. Adjacent the epithelium 21is the Bowman's membrane 22. The central portion of the cornea 20 is thestroma 23. The most inside, thin layer of the cornea 20 is theendothelium 24. The sclera 13 is the white portion of the eyesurrounding the outside of the cornea 20. The boundary of the cornea 20and the sclera 13 is the limbus 14. Behind the cornea 20 is the anteriorchamber 30. The lens 31 is next. The retina 32 is the lining of theinside of the eye 10 that is able to differentiate and receive the lightthat is allowed in through the cornea 20 and lens 31.

FIG. 3 is a side view of the front portion of an eye 10 in which aninsert 41 has been placed within a channel 40 in the stroma 23 of theeye. The channel 40 is a substantially flat, planar space that has beenformed within the stroma 23. In this example, the channel 40 is annularin shape in that there is an outer diameter and an inner diameter thatdefines an opening within the inside of the inside diameter of thechannel 40. As seen in FIG. 3, the width of the channel 40 isapproximately the same width as the iris 12. In this way, the insert 41that is placed within the channel 40 may adjust the apparent color ofthe iris 12 that is behind it. A second person who is looking at the eye10 of the first person will view the color of the eye, as defined by thecolor of the iris 12 and insert 41, as a uniform color. As shown in FIG.3 and FIGS. 3A-D, the outside diameter of the insert 41 is proximate thelimbus 14, especially when viewed from the front of the eye 10. When thepurpose of the channel 40 is solely as a space in which the insert 41 isplaced, the channel is very thin. The channel 40 may have a thickness ofapproximately 1 micron. A laser technique can evaporate 1 micron or moreof the stroma to create the channel. In one example, the thickness ofthe channel 40 is 3 microns or less with the material placed in it. Thechannel 40 can be created to make the net gain to the total thickness ofthe cornea 20 be approximately zero. The thickness of the channel 40will depend on how thin of an insert 41 can still delivercolor-modifying properties.

In FIGS. 3A and 3B, there is demonstrated the common anatomic situationwhere the width W₁ of the channel 40 remains constant, however the iris12 may change from a particular size 12 a, thereby creating a pupil size11 a to a more contracted size 12 b, thereby creating a smaller pupil 11b. This would occur, for instance, when a person becomes subjected torelatively bright lighting conditions in FIG. 3B versus 3A. The width Wof the channel 40 may be narrowed as shown in FIG. 3C where the width W2is substantially less than the width of the iris 12 c. Alternatively,the width W3 of the channel 40 may be wider than the iris 12 d. Assumingthat the iris 12 shown in FIG. 3 is of a size corresponding to normaldaylight, then the inside diameter of the channel 20 is located so thatit is proximate the normal daylight diameter of the iris. As is evidentfrom the other alternatives shown, however, the width of the channel 40may vary. For instance, in FIG. 3C, a patient may have congenital ortraumatic damage to only the outside of the iris 12 c. In that case, thechannel 40 c is only necessary to cover approximately the outside halfof the iris in its normal daylight diameter. An insert may be relativelymore colorized beyond the dilated pupil area to minimize night visioneffects as necessary as determined by study.

As shown herein, the channel 40 substantially encircles the pupil 11 ofthe eye 10. In this way, a regular and consistent color or pattern of aninsert 41 may give a regular eye pattern appearance. Also, the channel40 is shown as generally being symmetrical. It does not need to besymmetrical. The inside diameter and outside diameter of the channel 40may define a shape other than a circle. Also, the inside diameter maynot be centered within the outside diameter of the channel 40. The shapeof the channel 40 may be varied and adjusted as required by the specificcircumstances of a given patient.

FIG. 7A shows an eye having an annular colored portion 75, the normaliris 76 inside the colored portion, and the pupil 71. This figuredemonstrates that an insert that defines the colored portion 75 does notalways cover and hide the iris 76. Anatomically, this is natural, asnatural eye color often has different eye color shown across the widthof an iris.

The insert 41 may be comprised of any material that includes portionsthat are opaque. An insert 41 is typically not completely opaque.Complete opacity inherently requires a solid object. For the health ofthe eye, the insert is required to be permeable to allow the flow ofnutrients across the stroma 23. Examples of acceptable inserts 41include a slurry of biocompatible material, a fabric including opacifiedmaterial, and a thin permeable film material including some opaquematerials. Of course others of skill in the art will devise otheracceptable inserts that are covered by the scope of the presentinvention. Also, the insert 41 as shown has a relatively uniform color(degree of opacity) across the width. The insert 41 may alternativelyhave a color gradient or other variable pattern across its width. Asnoted earlier, it may be beneficial for night vision (when the pupil isrelatively dilated) for the opacity at the center of the insert 41 (nearthe pupil 11) to be relatively low.

In FIG. 4, an eye 10 has an ordinary pupil 11 and an insert 50surrounding the pupil. The insert 50 is above the iris that gives thevisual effect of being the iris. The insert 50 is a slurry ofbiocompatible material that has been injected into the stromal channel40 that has been formed directly above, the iris as described earlierherein in connection with, for example, FIGS. 3A-D. The biocompatiblematerial is opacified in the color appropriate to accomplish the desiredcolor change. For example, if deep blue eye color is the desired effect,a deep blue-gray, blue-purple or blue-blue slurry would be used. Asshown in FIG. 4A, flat or spherical particles 51 are dispersed within agel carrier 52 to form the slurry. The use of particles 51 permits fluidand nutrients to normally pass through the stromal tissue. Thebiocompatible material is placed in the channel in an appropriatedensity without altering the corneal shape, assuming that no shapechange is desired. The particles 51 may be composed of many materialsknown to be biocompatible including hydrogels, polytetrafluoroethylene(PTFE), and polymethymethacrylate (PMMA). Referring to FIG. 4A, theparticles 51 may include small beads 55 of PMMA that could be coated orotherwise dispersed inside of hydrogel 56 to further reduce any immuneresponse to the foreign bodies in the stroma and to reduce movement andextrusion. The hydrogel 56 could also be dosed with anti-inflammatoryagents to further reduce immune reactivity. The color used to tint theparticle 51 could be stabilized in the hydrogel or in the PMMA or otherslurry material to prevent leaching and potential toxicity. Even toxicmaterials can be encased in PMMA safely. The particles 51 should besmall, under about 3 microns of thickness, to minimize refractiveeffect. The shape of the particles could be flat round, spherical,ovalized, diamond-shaped, star-shaped, triangular or any other geometricconfiguration that provides a desirable color effect or other visualeffect with the least amount or predetermined amount of optical effect.

The biocompatible material may have UV absorbing quality and couldreduce the UV exposure at the peripheral edge of the pupil 11. Likewise,in the event of a congenital or traumatic flaw in the pupil, the UVprotecting material could prevent additional, unwanted light fromgetting into the inside of the eye.

It is expected that the particles will include current materials used incontact lens and other optical applications. Ideally, the biocompatiblematerial will display even color distribution, will have minimal to norefractive or refractile quality, will be stable and non-inflammatory,and will remain stable in place in the stroma without drifting orextrusion. Although, as noted earlier, the material may be more or lesstinted across the width of the channel for various, intended purposes.

Currently, color is provided by contact lens through use of linearsections of color in various patterns that are designed to fool anobserver into seeing the color as one does with the iris of the eye.Referring to FIG. 10, linear inlays could be fashioned using a slurry ofmaterials and placed in the stromal space in a manner to duplicate thiseffect. As shown in FIG. 10, radial channels 110 extend from an insideend proximate the pupil 11 outwardly. An insert 111 is placed withineach channel 110. The insert 111 may be the slurry already discussedherein or the fabric or film discussed subsequently herein. The radialchannels 110 may be formed all around the pupil 11 or only partiallyaround it. The width and number of radial channels may also vary asneeded. The fabric or film insert that may be placed in a radial channel110 may be rolled and inserted by using a plunger and syringe that isinjected into each channel.

Another type of acceptable biocompatible material that may be placedwithin the channel 40 is a fabric 60 of at least partially opacifiedmaterial as shown in FIG. 5. The fabric insert 60 may be woven, spun,non-woven, electrospun, or any other type of fibrous substrate.Inherently, the fabric that is placed into the channel has gaps andholes to allow for healthy permeability through the fabric. The fabricmay itself be the web that opacifying material is supported by, or thefabric could be comprised of fibers that are impregnated with theopacifying material. The use of a fabric insert 60 allows theintroduction of a uniform amount of material into a channel within thestroma. The fabric may also facilitate removal of the insert if thisever became necessary or desirable. The fabric may be comprised of anybiocompatible materials including, but not limited to, PMMA, hydrogel,PTFE, stabilized hydrophilic polymers and newer biologically stabilizedmaterials. These materials, along with the inherent porous nature of thefabric, allow for the transfer of nutrients and oxygen across theinsert. The fabric insert may have any thickness that does notmaterially affect the refractive performance of the eye when placed forcolor modification only. Thicknesses included, in some examples, 5microns or less or 3 microns or less. It can also be seen that thefabric may include patterns that are woven or otherwise formed withinthe fabric. The patterns may include a gradient of opacity from leastopaque in the center to more opaque when moving outwardly.

A still further alternative insert includes a thin polymer film that isnevertheless highly permeable. It must be very thin to allow for colorwithout refractive change. Preferably, the solid film insert 70 has athickness of 5 microns or less or, alternatively, 3 microns or less. Thesolid film insert 70 is placed outside the pupil margin and could beextruded into place within the channel using an injection system similarto those systems used in refractive implant surgery currently.Acceptable film materials include those referenced earlier with respectto the fabric of opacified material. Those of skill in the art willunderstand how to treat or process the film in order to obtainsufficient permeability to provide for nutrients flow through the insert70. Films may be also imprinted with various patterns and colorgradients.

As indicated earlier, the visual appearance of the insert may becarefully prepared to mimic a human iris. Alternatively, other naturalor geometric designs may be desired for therapeutic or cosmeticpurposes. FIG. 7B is a visual example of different designs that may bedisplayed in an insert 80. Most likely, the seven different designsshown in the insert 80 would not be used together. However, it possiblethat a person would want more than one geometric design to be visible inthe eye. Further, it may be therapeutically important to have differentvisual effects across the area of the insert 80. For instance, theamount of UV absorbance may be graded across the width of the insert.

While all of the figures display an insert that maintains an insideopening corresponding to the pupil 11, there is no requirement that theinsert could not likewise span across the pupil 11. This is somethingthat must be done carefully in view of the potential distortion of thevisual light that maybe received by the human eye. However, for instancein the example of a very sensitive retina, a person mighttherapeutically benefit from UV protection across the entire cornea.

The insert and channel and discussion herein has emphasized the minimalor lack of effect of the insert on the refractive performance of theeye. However, it is possible to use these inserts and the process ofplacing them in the eye to alter corneal curvature and to match the eyeto wavefront topography or other aberrational systems and to shape thecornea to a more perfect oblate shape. To this end, the insert could bemade thicker or thinner in the area needed to match the shape orwavefront topography. The insert could be made slightly thicker orthinner to give the effect of normalizing the corneal curvature. Manyaberrational visual effects occur at the periphery of the vision, andthese could be positively altered by the use of a custom-shapedperipheral insert as described herein. The ability of the material toabsorb a certain wavelength of light and to be altered in shape could bean excellent adjunct to current techniques of treating the cornealstroma. In one alternative, the insert may be preformed externally andplaced within the cornea. The opacified material may be especiallyselected for the purpose of fine tuning the shape of the insert at alater date, because the material may absorb light energy and specificwave lengths that would allow the material to expand or contract uponheating. This allows for matching refraction or aberration with anexternal treatment.

Still further additionally, the biocompatible material that makes up theinsert may further include photocromatic components. These componentsmay darken or lighten as a result of the effective light or other energysuch as magnetism. This type of material could be used to externallymanipulate the eye color or improve solar protection.

Different methods may be used to modify eye color. In the broadestterms, the different methods include use of a surgical blade and/or atype of laser. A common procedure currently includes use of amicrokerotome to cut through the outer cornea creating a corneal “flap”that is lifted up to expose the stroma. For the purpose of the presentmethod, the microkerotome or other surgical blade could be used tocreate the channel into which a colored insert may be placed.Microkeratomes were designed to create a “window” called a flap underwhich a 5 to 10 millimeter laser treatment would be placed. Thereforethe current design of microkerotomes is probably too small for thispurpose. Different modified keratomes could be developed. Ideally theflap does not need to be created and a channel could be made by anothermethod.

An alternative, laser-based method, includes the use of a pulsionfemtosecond laser. This laser eliminates the need for a microkerotomecut by instead generating a rapid, low-energy plasma pulse to separatethe cornea from the stroma. After the stroma is separated from thestroma, a small slit may be cut in the cornea to gain access to thechannel formed by the laser. The slit is preferably made in the corneaabove the upper eyelid or below the lower eyelid. This slit is then usedto place the insert into the channel. In the example of a slurry, thematerial may be injected around the channel. The fabric or film may havea cut across it to create an end that may then be taken around thechannel. Further, the fabric or film could be extruded into the channelwith an inserter that pushes out the insert as the surgeon withdraws theinserter out of the channel.

A tattoo technique may also be used to place the particles into thestroma or Bowman's membrane layering the particles under the surface andin the stroma at the same or similar level as the channel and beingextruded into the channel area with a needle. As shown in FIG. 11, asyringe 125 having a needle 126 of predetermined length is used toinject particles 130 or a slurry into the stroma 132 at a specificdepth. The needle 126 passes through the epithelium 120 and Bowman'smembrane 121. Like a tattoo, many different designs are possible.

The depth of the channels would in general be in the stroma and underthe Bowman's membrane and would be developed by experience. In oneexample, the depth would be at the 100 to 150 micron level. Analternative argument would be to place inserts deeper into the stroma toallow for corrective procedures on the surface of the eye. The widthwould be from the mesoptic pupil edge to the limbus or near the limbus.An alternate approach would be to have the channels be radial tracksmoving toward the pupil from the limbus. These would be, in one example,1 to 2 millimeters wide and at the same depth. The inserts could beinserted with an extrusion instrument and could be withdrawn down thesame path if necessary. These tracks would be created with thefemtosecond laser or with a bladed instrument similar to theintrastromal implants known as Intacs. They also could be graded inthickness to allow for refractive alteration as well.

A still further method of modifying eye color is demonstrated in FIGS. 8and 9. In this alternative method, the epithelium 101 of a cornea 100 isremoved from the top of the eye. This exposes the Bowman's membrane 102.The portion of epithelium 101 that is removed is preferably annular inshape to leave intact the entire cornea along the optic axis of the eye.The Bowman's membrane 102 may then be stained or tattooed to anappropriate color or design or other visual image. Then the epithelium101 either grows back or is placed back on top of the Bowman's membrane,thereby encapsulating the modified eye color. In this example, theepithelium 101 may be separated from the Bowman's membrane 102 usinglaser techniques, or alternatively using surgical blade-based techniques(e.g., using an epi-keratome).

While the invention has been described with reference to specificembodiments thereof, it will be understood that numerous variations,modifications and additional embodiments are possible, and all suchvariations, modifications, and embodiments are to be regarded as beingwithin the spirit and scope of the invention.

1. A method of modifying eye color comprising the steps of: forming anannular channel within a plane around and encircling the pupil of aneye, wherein the channel is located in the stroma portion of the eye andhas annular borders proximate the limbus and the daylight margin of thepupil; slitting the cornea of the eye to gain access to the channel;inserting into the channel a biocompatible material, wherein thebiocompatible material is comprised of a polymer fabric having athickness of approximately 1-5 microns, and being at least partiallyopacified in a color appropriate to accomplish a desired color change;wherein the net gain to the total thickness of the cornea isapproximately zero, and the inserted material does not materially affectthe refractive performance of the cornea while providing said colorchange and said material permits fluid and nutrients to pass through thestromal tissue.
 2. A method of modifying eye color as described in claim1, wherein the fabric is comprised of a polymer selected from the groupconsisting of natural polymers, synthetic polymers,polymethylmethacrylate, hydrogel, polytetrafluoroethylene, hydrophilicpolymers and combinations thereof.
 3. A method of modifying eye color asdescribed in claim 1, wherein the channel is formed by using a lasertechnique.
 4. A method of modifying eye color as described in claim 3,wherein the laser technique includes the use of a femtosecond laser. 5.A method of modifying eye color as described in claim 1, wherein thechannel is formed by using a surgical blade.
 6. A method of modifyingeye color as described in claim 5, wherein the surgical blade is amicrokeratome.
 7. A method of modifying eye color as described in claim1, wherein the inserted material comprises a photochromic material.
 8. Amethod of modifying eye color as described in claim 1, wherein thefabric includes patterns that include a gradient of opacity from leastopaque in the center to more opaque when moving outwardly.
 9. A methodof modifying eye color as described in claim 1, wherein the fabric iswoven, spun, nonwoven or electrospun.
 10. A method of modifying eyecolor comprising the steps of: forming an annular channel within a planearound and encircling the pupil of an eye, wherein the channel islocated in the stroma portion of the eye and has annular bordersproximate the limbus and the daylight margin of the pupil; slitting thecornea of the eye to gain access to the channel; inserting into thechannel a biocompatible material, wherein the biocompatible material iscomprised of a polymer film having a thickness of approximately 1-5microns, and being at least partially opacified in a color appropriateto accomplish a desired color change; wherein the net gain to the totalthickness of the cornea is approximately zero, and the inserted materialdoes not materially affect the refractive performance of the corneawhile providing said color change and said material permits fluid andnutrients to pass through the stromal tissue.
 11. A method of modifyingeye color as described in claim 10, wherein the film is comprised of apolymer selected from the group consisting of natural polymers,synthetic polymers, polymethylmethacrylate, hydrogel,polytetrafluoroethylene, hydrophilic polymers and combinations thereof.12. A method of modifying eye color as described in claim 10, whereinthe channel is fog Hied by using a laser technique.
 13. A method ofmodifying eye color as described in claim 12, wherein the lasertechnique includes the use of a femtosecond laser.
 14. A method ofmodifying eye color as described in claim 10, wherein the channel is fogHied by using a surgical blade.
 15. A method of modifying eye color asdescribed in claim 14, wherein the surgical blade is a microkeratome.16. A method of modifying eye color as described in claim 10, whereinthe inserted material comprises a photochromic material.
 17. A method ofmodifying eye color as described in claim 10, wherein the film includespatterns that include a gradient of opacity from least opaque in thecenter to more opaque when moving outwardly.